Factor XA - Inhibition in RENal Patients With Non-valvular Atrial Fibrillation - Observational Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- GWT-TUD GmbH
- 入组人数
- 1,700
- 试验地点
- 116
- 主要终点
- major bleeding
研究概览
简要总结
The multicenter registry will collect clinical data from 1600 patients with non valvular atrial fibrillation (NVAF) and chronic kidney disease (eGFR 15-49 mL/min per 1.73 m2).
The overall objective of this registry is to assess chronic kidney disease (CKD) progression and clinical outcomes with regard to anticoagulation strategies in NVAF patients with eGFR 15-49 mL/min per 1.73 m2 in routine clinical practice.
详细描述
This is a prospective registry allowing a structured, non-interventional collection of data. Participating physicians will not be subject to any instructions with regard to the diagnosis and therapy of their patients. All patient treatment is carried out within clinical routine, at the discretion of the physician and according to existing treatment guidelines.
This registry will be carried out as an investigator-initiated, multicentre, prospective, non-interventional and observational registry at approximately 160 sites in Germany, Austria, Switzerland, France, Belgium and Luxembourg.
The registry will collect clinical data of approximately 1600 patients with CKD (eGFR 15-49 mL/min per 1.73 m2) and NVAF receiving rivaroxaban, OAC with VKA, or no AC therapy, who are prospectively followed for a flexible duration with a minimal follow-up duration of 12 months until study end is announced (planned minimum 360 days / planned maximum 84 months).
The plan of the registry is to include at least 1600 patients with CKD and NVAF and rivaroxaban therapy or VKA therapy or no AC therapy.
The aim is to include at least 700 patients with rivaroxaban therapy and VKA therapy, respectively. Into the exploratory treatment arm of patients receiving no AC therapy about 100 patients will be included.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female patients, age ≥ 18 years
- •CKD with eGFR 15 - 49 mL/min per 1.73 m2
- •non-valvular atrial fibrillation (NVAF) with indication for anticoagulation therapy
- •a treatment strategy for the ≥ 3 previous months before enrolment with either: rivaroxaban or VKA (OAC cohorts) or no anticoagulation (no AC cohort)
- •informed consent
- •availability for follow up
- •life expectancy of ≥6 months
排除标准
- •exclusion criteria according to the local product information for the respective anticoagulation treatment
- •planned treatment with other anticoagulants
- •expected renal-replacement therapy within the next 3 months
结局指标
主要结局
major bleeding
时间窗: 12 month
decline in eGFR in mL/min per 1.73 m2
时间窗: 12 month
all-cause mortality
时间窗: 12 month
major cardiovascular events (MACE)
时间窗: 12 month
symptomatic venous thromboembolic events
时间窗: 12 month
net-clinical benefit (stroke and other thromboembolic events, major bleeding, and all-cause mortality)
时间窗: 12 month
TIA, stroke or systemic arterial embolism
时间窗: 12 month
次要结局
- initiation of chronic renal replacement therapy(12 month)
- length of hospitalizations(12 month, 18 month)
- reasons for OAC therapy discontinuation(12 month, 18 month)
- eGFR < 15 mL/min per 1.73 m2 (CKD Stage 5 Dialysis and Non-Dialysis)(12 month)
- doubling of serum creatine concentration(12 month)
- acute kidney injury (AKI) events defined as acute kidney injury associated with either hospitalization or emergency department visit, where AKI event is the lead diagnosis(12 month, 18 month)
- causes of hospitalizations(12 month, 18 month)
- eGFR decline of ≥ 30%(12 month)
- rates of hospitalizations(12 month, 18 month)
- persistence with OAC therapy(12 month, 18 month)